SCOTTS SELECT NEPHRO-STAT- aluminum chloride solution

Scotts Select NEPHRO-stat by

Drug Labeling and Warnings

Scotts Select NEPHRO-stat by is a Prescription medication manufactured, distributed, or labeled by Scott's Dental Supply LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NDC# 69638-059-20

25% Aluminum Chloride

30cc

INSTRUCTIONS FOR USE

Drug Facts

DESCRIPTION

Active Ingredient	Purpose
25% Aluminum Chloride	Astringent

USES

Nephro-Stat is a topical astringent solution of Aluminum Chloride. Gingival retraction can be achieved using a plain gingival retraction cord moistened with Nephro-Stat. Stops gingival bleeding fast. If you should inadvertently damage the gingival margin during tooth preparation or while placing a strip, a band or a cervical matrix, moisten the area with Nephro-Stat which will control and stop bleeding quickly.

Nephro-Stat contains no epinephrine. The use of vasoconstrictors for gingival retractions and bleeding is potentially dangerous and should be avoided.

A plain gingival retraction cord can be dipped in Nephro-Stat solution and then placed into the gingival sulcus for its hemostatic action.

WARNINGS

• Discontinue use if irritation appears.
  For topical application only.
• Avoid eye contact.
• Do not use in patients with a known history of hypersensitivity to aluminum chloride.
• For professional use only.
• Federal law restricts the product to sale or use on the order of a dentist.

DIRECTIONS FOR USE

• Soak a cotton tipped applicator with Nephro-Stat.
• Apply to bleeding area with pressure until bleeding is stopped. Should a small dark coagulation appear, flush it away with water.
  This will have no effect on hemostatic action.
• Remove the impregnated cord from sulcus.
• Flush with water and air dry until bleeding is no longer present.

OTHER INFORMATION

Store at 59° – 86°F (15° – 30°C).

Protect from freezing.

INACTIVE INGREDIENTS

Benzyl Alcohol, Distilled Water, Potassium Chloride, Propylene Glycol

CAUTION

Federal (USA) law prohibits dispensing without a prescription.

Contains no epinepherine.

Storage	Read usage instructions	Allergies & Precautions

USA
Rx Only

FOR TOPICAL APPLICATION

FOR PROFESSIONAL USE ONLY

SPL UNCLASSIFIED SECTION

Rev. A, Date: 6/30/2016

REORDERING

To reorder Scott's Select Nephro-Stat please call customer sercive at 1-800-901-3368 or by visitng WWW. SCOTTSDENTAL.COM using reorder number 245-0113.

FEATURES

• Nephro-Stat is a buffered 25% Aluminum Chloride Solution which contains Aluminum Chloride 6-hydrate 25% in an aqueous vehicle with buffering agents.
• Nephro-Stat is epinephrine-free to prevent cardiac reactions.
• Nephro-Stat effectively stops minor gingival bleeding.
• It is recommended to arrest bleeding during crown preparations, before impression taking, for minor surgery, curettage, gingivectomies, and deep scaling.
• Nephro-Stat is easily absorbed by retraction cords.

SPL UNCLASSIFIED SECTION

Mfg for: Scott's Dental Supply
Fife, WA 98424
1-800-901-3368
WWW.SCOTTSDENTAL.COM

PRINCIPAL DISPLAY PANEL - 30 cc Bottle Label

NDC# 69638-059-20

Scott's
SELECT
NEPHRO-STAT
HEMOSTATIC SOLUTION
25% Aluminum Chloride

REORDER 245-0113

30cc

Mfg for: Scott's Dental Supply
Fife, WA 98424
1-800-901-3368
WWW.SCOTTSDENTAL.COM

INGREDIENTS AND APPEARANCE

SCOTTS SELECT NEPHRO-STAT 
aluminum chloride solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69638-059
Route of Administration	DENTAL, ORAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM CHLORIDE (UNII: 3CYT62D3GA) (ALUMINUM CATION - UNII:3XHB1D032B)	ALUMINUM CHLORIDE	7500 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Product Characteristics
Color	white (colorless)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69638-059-20	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		01/01/2013

Labeler - Scott's Dental Supply LLC (137217043)